Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Unity Subcutaneous Delivery System for Remodulin

K-Number: K190182 · 2019-05-06

ApplicantDEKA Research & Development
Decision Date2019-05-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Unity Subcutaneous Delivery System for Remodulin is a medical device manufactured by DEKA Research & Development. It received FDA 510(k) clearance on 2019-05-06 under approval number K190182. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unity Subcutaneous Delivery System for Remodulin?

Unity Subcutaneous Delivery System for Remodulin is a medical device that received FDA 510(k) clearance on 2019-05-06. It is manufactured by DEKA Research & Development. The 510(k) number is K190182.

When was Unity Subcutaneous Delivery System for Remodulin approved by the FDA?

Unity Subcutaneous Delivery System for Remodulin received FDA 510(k) clearance on 2019-05-06, under approval number K190182.

What company makes Unity Subcutaneous Delivery System for Remodulin?

Unity Subcutaneous Delivery System for Remodulin is manufactured by DEKA Research & Development.

What is the FDA product code for Unity Subcutaneous Delivery System for Remodulin?

The FDA product code for Unity Subcutaneous Delivery System for Remodulin is FRN.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT06847542 A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD RECRUITING

Other Devices by DEKA Research & Development

K153760Volumetric Infusion Controller K191313Unity Subcutaneous Infusion System for Remodulin

Related Devices (Code: FRN)

K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. K161667Sapphire Infusion PumpQ Core Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑